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Cardiac Resynchronisation Study

Sponsor
Imperial College London (Other)
Overall Status
Completed
CT.gov ID
NCT01213537
Collaborator
(none)
182
Enrollment
1
Location
12
Duration (Months)
15.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to investigate the effect of a pacemaker device used in heart failure patients which is called Cardiac Resynchronisation Therapy (CRT). Specifically the investigators aim to investigate if the CRT pacemaker has an effect on breathing stability in these patients and particularly breathing stability at night. Our theory is that the CRT pacemaker may improve the stability of breathing in patients with heart failure.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    AIM To investigate the effect of Cardiac Resynchronisation Therapy (CRT) on chemosensitivity in patients with Chronic Heart Failure with and without Sleep Disordered Breathing (SDB).

    OBJECTIVE To conduct a physiological observational study to measure hypercapnic ventilatory responses in a group of CHF patients before and 3 months after implantation of clinically indicated CRT devices. Additionally to conduct nocturnal polysomnography to establish if any change in chemosensitivity is related to the presence of SDB at baseline and, where present, any change in SDB after implantation.

    HYPOTHESIS Primary hypothesis: CRT implantation will be associated with a reduction in the hypercapnic ventilatory response from baseline to 3 months post implantation.

    Additional hypothesis: This reduction in hypercapnic ventilatory response after CRT implantation will be greatest in those CHF patients with SDB at baseline.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    182 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Study of the Effect of Cardiac Resynchronisation Therapy (CRT) on Chemosensitivity in Patients With Chronic Heart Failure With and Without Sleep Disordered Breathing.
    Study Start Date :
    Oct 1, 2010
    Actual Primary Completion Date :
    Oct 1, 2011
    Actual Study Completion Date :
    Oct 1, 2011

    Arms and Interventions

    Arm Intervention/Treatment
    Patients undergoing clinically indicated CRT implantation

    Patients may be included in the study if they fulfil the following; Age ≥18 years old Fulfil the current guidance for the implantation of a CRT device; optimal medical treatment for heart failure, broad QRS complex on electrocardiogram with or without evidence of cardiac dyssynchrony as appropriate, LVEF <35%, functional impairment as defined by an NYHA class of III-IV Clinically stable with no unplanned admission to hospital for preceding 4 weeks No changes in medications for heart failure in preceding 4 weeks Able to read and understand patient information sheet and give informed consent Patients must be excluded from the study if they fulfil they the following; On positive pressure treatment for known sleep disordered breathing at the time of inclusion Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc. Pregnancy

    Outcome Measures

    Primary Outcome Measures

    1. Change in chemosensitivity before and after CRT implantation [3 months]

      We will look primarily at the effect of CRT implantation on chemosensitity which we will measure using the ventilatory sensitivity to carbon dioxide.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age ≥18 years old

    2. Fulfil the current guidance for the implantation of a CRT device; optimal medical treatment for heart failure, broad QRS complex on electrocardiogram with or without evidence of cardiac dyssynchrony as appropriate, LVEF <35%, functional impairment as defined by an NYHA class of III-IV

    3. Clinically stable with no unplanned admission to hospital for preceding 4 weeks

    4. No changes in medications for heart failure in preceding 4 weeks

    5. Able to read and understand patient information sheet and give informed consent

    Exclusion Criteria:

    1. On positive pressure treatment for known sleep disordered breathing at the time of inclusion

    2. Other known condition (untreated) likely to significantly disturb sleep eg. Restless legs syndrome, pain from any cause etc.

    3. Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Brompton Hospital London United Kingdom SW3 6NP

    Sponsors and Collaborators

    • Imperial College London

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Rebecca Lucas, Mrs, Imperial College London
    ClinicalTrials.gov Identifier:
    NCT01213537
    Other Study ID Numbers:
    • 10/H0706/5
    First Posted:
    Oct 4, 2010
    Last Update Posted:
    Oct 22, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Rebecca Lucas, Mrs, Imperial College London
    Heart failure
    Additional relevant MeSH terms:
    Heart Failure

    Study Results

    No Results Posted as of Oct 22, 2015